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cGMP Stable Cell Line

With substantial experience in protein expression and advanced cell line engineering platform, Creative Biolabs provides comprehensive cGMP stable cell line construction services starting from DNA sequence and ending with the delivery of top quality stable single clones. Owning all the key actuate variables for the service, housing various host cell lines (microbial and mammalian cell lines), vector technology and clone-adopted media platform, as well as FDA approved cGMP facilities and professional work team, Creative Biolabs provides full cell line development services for biomanufacturing using the following host cells:

Selection of Initial Stable Producing Pools

Creative Biolabs grows transfected cells in the appropriate selective media to generate stable pools. At least top 3 pools move to next cloning step depending on the productivity and quality of the pools.

Cloning

Semi-solid medium plating or serial dilution is performed on the top 3 pools are for clone-pecking. And at least top 10 clones from each pool (the number can be extended upon request) are selected.

Fed -batch Evalution & Top Clones Selection

The top 10 clones from each pool are further evaluated based on their growth rate to capture 5-6 best clones. Different strategies can be applied to evaluate the productivity of the clones such as quantitative ELISA or fed-batch cultivation. And the final 3 top clones with robust cell growth and high productivity are selected based on the screening data.

Productivity & Stability Study

Creative Biolabs evaluates the yield and the stability of the final top clones for up to 60 generations (the duration can be extended upon request). The genetic stability of the final clones is evaluated by sequencing the full length of the target gene.

Final Deliverables, QC Data& Full Report

Creative Biolabs provides the top stable clone and comprehensive document report covering the stable cell line generation and all QC data.

To discuss your cGMP Stable Cell Line demands or to request a proposal, please contact us by